MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012274-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient presented with a heavily calcified, popliteal to femoral bypass graft.Difficulty accessing the heavily lesion site was observed.Following, the operator advanced a trek rx dilatation catheter without an advancement issue to the graft site.Successful dilatation was performed eight times.During device removal, resistance was then observed with the trek rx catheter due to the heavy calcification and the trek proximal shaft separated.A snare was unsuccessful at removing the separated portion.The patient was then taken to surgery and an open surgical cut down was performed, removing the separated portion.There was no adverse patient sequela following.There was no clinically significant delay.The patient is in fine and stable condition.No additional information was provided regarding this issue.
Event or Problem Description
Subsequent to the initial report filed, user facility medwatch report (mw5097052) received stating: "shaft of the abbott trek balloon broke off in patient's right leg during angioplasty procedure." the facility reporter was contacted and the correct device was confirmed as trek coronary dilatation catheter 1012274-20, lot 90220g1.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal interaction with the heavily calcified anatomy resulted in the reported difficult to remove.Manipulation of the device resulted in the noted multiple device damages (bent inner member, kinked inner member/skive, kinked support skive/wire/bayonet, multiple hypotube bends) and ultimately resulted in the reported material separation.The noted chatter marks on the outer member likely resulted from interaction with other devices.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10645895
• Report Number: 2024168-2020-08363
• Device Sequence Number: 2438856
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: 08717648138447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 1012274-20
• Device Catalogue Number: 1012274-20
• Device Lot Number: 90220G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR